On 29 August 2024, Biocon Ltd announced that it has signed a patent settlement and licence agreement with Janssen which enables Biocon to commercialise Bmab 1200 (ustekinumab), biosimilar to Janssen’s Stelara®, in Europe, the United Kingdom, Canada and Japan. Biocon has submitted regulatory applications in each of these jurisdictions.

The Biocon-Janssen patent settlement and licence agreement follows the US settlement agreement in February 2024 enabling Biocon to launch Bmab 1200 in the US in February 2025.  In May 2024, Biocon announced that the FDA accepted its BLA for Bmab 1200 for review under the 351(k) pathway.

Biocon reported in August 2024 year-on-year consolidated revenue growth of 30% for Q2 2024, with its biosimilars business delivering year-on-year growth of 11% compared with the same quarter last year.

JAMP recently filed an application in the Canadian Competition Tribunal seeking leave to bring an action under the Competition Act regarding Stelara® (ustekinumab).  JAMP alleges that Janssen has abused its dominant market position, in contravention of section 79 of the Competition Act by “…gam[ing] the pharmaceutical regulatory system and use[ing] sham litigation to disincentivize rivals from launching their own ustekinumab drugs”.

If JAMP succeeds in its leave application, it intends to seek a range of orders designed to curb Janssen’s alleged anti-competitive conduct as well as an order for a monetary penalty 3 times the value of the benefit which Janssen has derived from alleged anti-competitive conduct, estimated by JAMP to be at least $1 trillion.

In March this year, JAMP launched the first ustekinumab biosimilar to Janssen’s Stelara® in Canada. The Alvotech-developed Jamteki^™ was approved by Health Canada in November 2023. The March 2024 launch followed a settlement between Alvotech and J&J in February 2024 regarding ustekinumab.

On 31 July 2024, Celltrion reported that Health Canada has approved its new drug licence application for Steqeyma (CT-P43), biosimilar to Janssen’s Stelara® (ustekinumab), for plaque psoriasis, psoriatic arthritis, and Crohn’s disease.

The Health Canada approval follows EMA’s recommendation for European marketing authorisation for Steqeyma and Celltrion’s earlier approval for Steqeyma in Korea on 12 June 2024.  Celltrion is also seeking approval for Steqeyma in the United States and Australia, submitting applications with FDA in June 2023, and TGA in April 2023.

On 18 March 2024 Fresenius Kabi and Formycon announced they reached a settlement with Johnson & Johnson regarding the commercialisation of FYB202, biosimilar to J&J’s Stelara® (ustekinumab) in Europe and Canada.  The announcements did not disclose the permitted launch dates for FYB202 in those regions.

In August 2023 the companies announced they had reached a settlement in the US with Johnson & Johnson for FYB202, enabling US launch “no later than 15 April 2025”.

Amgen announced that Wezlana™ (ustekinumab injection) and Wezlana™ (ustekinumab for injection, solution for intravenous infusion), biosimilar to Janssen’s Stelara®, is now available in Canada.  Wezlana™ is the first biosimilar to be approved by Health Canada for all Stelara® indications, but the second ustekinumab Canadian launch following the launch of  the first ustekinumab biosimilar (Jamteki™) in Canada by JAMP Pharma on 1 March 2024.   

Jamteki™ was developed by Alvotech and was approved by Health Canada in November 2023. 

On 1 March 2024, JAMP Pharma announced that it launched the first ustekinumab biosimilar to Janssen’s Stelara® in Canada.  Jamteki™ was approved by Health Canada in November 2023 and JAMP’s launch follows a settlement between Alvotech and J&J last month regarding ustekinumab. 

Jamteki™ was developed by Alvotech and is JAMP Pharma’s second biosimilar launch in Canada in two years, following the Canadian launch of Simlandi® (adalimumab) biosimilar of AbbVie’s Humira® (adalimumab) in 2022.  The approved presentations for Jamteki™ are a 45mg/0.5mL and 90mg/mL pre-filled syringe with a passive safety device for subcutaneous injection. 

On 21 November 2023, the Canadian Federal Court of Appeals dismissed Janssen’s appeal from a decision of the Federal Court upholding Canada’s Office of Submission and Intellectual Property (OSIP) refusal of Janssen’s application to list Canadian Patent 3113837 on the PMNOC register for two supplementary new drug submissions relating to Stelara® (ustekinumab).

The Federal Court decision was handed down in July 2023.

Alvotech and JAMP Pharma announced that Health Canada has granted marketing authorization for Jamteki™ (AVT04), the first approved biosimilar to Stelara® (ustekinumab) in Canada.  AVT04 was developed by Alvotech and will be marketed under the name Jamteki® by JAMP in Canada.  The approved presentations are a 45mg/0.5mL and 90mg/mL pre-filled syringe with a passive safety device for subcutaneous injection. 

This is the first approved ustekinumab biosimilar in Canda, and the second biosimilar to receive marketing authorisation in Canada under the exclusive commercialization partnership between Alvotech and JAMP Pharma (following Simlandi®, biosimilar to Abbvie’s Humira® (adalimumab)).  The companies announced their exclusive partnership for the commercialisation of five biosimilars in Canada in January 2020, which was expanded to seven biosimilars in October 2022.

The Canadian Federal Court upheld a decision of Canada’s Office of Submission and Intellectual Property (OSIP) to refuse Janssen’s application to list Canadian Patent 3113837 (‘837 patent) on the PMNOC register for two supplementary new drug submissions relating to Stelara® (ustekinumab) OSIP refused the application as the ‘837 patent application was filed in Canada after the submissions.

Health Canada approved ulcerative colitis as an indication for Stelara® on 27 January 2020.

Health Canada approves ulcerative colitis as an additional indication for Stelara®.